ANDA 210625, held by Eugia Pharma. Fosaprepitant Dimeglumine.
As of Nov 15, 2026, ANDA 210625 (Fosaprepitant Dimeglumine), held by Eugia Pharma, was first approved by FDA on Jan 12, 2021, with 4 approved supplements and 0 published complete response letters.
Fosaprepitant for injection, in combination with other antiemetic agents, is indicated in adults and pediatric patients 6 months of age and older for the prevention of: acute and delayed nausea and vomiting associated with initial and repeat courses of highly emetogenic cancer chemotherapy (HEC) including high-dose cisplatin. delayed nausea and vomiting associated with initial and repeat courses of moderately emetogenic cancer chemotherapy (MEC). Limitations of Use Fosaprepitant has not been studied for the treatment of established nausea and vomiting.
| Date | Submission | Status | Documents |
|---|---|---|---|
| Jan 12, 2021 | Original application | Approved | None posted |
| Product | Active ingredient | Marketing |
|---|---|---|
| Fosaprepitant DimeglumineEQ 150MG BASE/VIAL · powder;intravenous | Fosaprepitant Dimeglumine | Rx |
| Aug 7, 2026 | Supplement 8Labeling · Standard review | Approved | None posted |
| Oct 10, 2023 | Supplement 1Labeling · Standard review | Approved | None posted |
| Oct 10, 2023 | Supplement 3Labeling · Standard review | Approved | None posted |
| Oct 10, 2023 | Supplement 4Labeling · Standard review | Approved | None posted |
| Jan 12, 2021 | Original application | Approved | None posted |
Approvals, supplements, products and documents come from FDA's Drugs@FDA data files, refreshed daily; Drugs@FDA lists approved applications only. Complete response letters are FDA's published letters. Drugs@FDA and FDA complete response letters
